CBER
The article outlines the Q-Submission process, detailing regulatory requirements, clarifications, and recommendations to help stakeholders ensure compliance.
China
The new article provides an overview of the revised guidance dedicated to registration of medical devices intended to be marketed and used in China.
CMDE
The article describes in detail the approach to be followed by the parties involved in operations with digital medical devices in order to ensure the safety and proper performance of their products
Malaysia
The article provides a general overview of the regulatory framework for medical devices no longer supported by their manufacturers, emphasizing the key points to be taken into consideration in order to ensure the continued safety of patients.
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to design control in the context of medical devices. Among other matters, the document addresses aspects...
